ANSI AAMI 80369-1-2010 Small bore connectors for liquids and gases in healthcare applications Part 1 General requirements.pdf

1、ANSI/AAMI/ISO 80369-1:2010Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirementsAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product stan

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24、ich has not been developed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI/ISO 80369-1:2010 Smallbore connectors for liquids and gases in healthcare applications

25、 - Part 1: General requirements Approved 8 December 2010 by Association for the Advancement of Medical Instrumentation Approved 30 December 2010 by American National Standards Institute, Inc. Abstract: This covers general aspects of non-interchangeability and appropriate validation procedures for sm

26、all bore connectors for liquids and gases in healthcare applications. Keywords: liquids, gases, small bore connectors AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions. The

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31、tion for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2011 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Printed in the United States of America ISBN 1570204055 This publication is subject to

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35、tion for the Advancement of Medical Instrumentation (AAMI), including the standards on small-bore connectors (AAMI/ISO 80369 series), are developed through a voluntary consensus standards development process approved by the American National Standards Institute. This process brings together voluntee

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43、 a competent professional in determining the exercise of reasonable care in any given circumstances. Information on the topic of small-bore connectors may be available from other sources, which the user may wish to consult for additional views or information not covered by the draft or final standar

44、ds. AAMI and the AAMI Foundation have no power to, nor do they undertake to, police or enforce compliance with the contents of this standard. AAMI and the AAMI Foundation do not certify, test, or inspect products, designs, or installations for safety or health purposes. Any certification or other st

45、atement of compliance with any health or safetyrelated information in the standards shall not be attributable to AAMI or the AAMI Foundation and is solely the responsibility of the certifier or maker of the statement. Contents Page 1 Scope. 1 2 Normative references 2 3 Terms and definitions 2 4 Mate

46、rials used for SMALL-BORE CONNECTORS 4 5 Requirements for SMALL-BORE CONNECTORS for specific APPLICATIONS 4 5.1 SMALL-BORE CONNECTOR incompatibility . 4 5.2 BREATHING SYSTEMS and driving gases APPLICATIONS. 4 5.3 Enteral and gastric APPLICATIONS 4 5.4 Urethral and urinary APPLICATIONS 5 5.5 Limb cuf

47、f inflation APPLICATIONS . 5 5.6 Neuraxial APPLICATIONS 5 5.7 Intravascular or hypodermic APPLICATIONS 5 5.8 Alternative SMALL-BORE CONNECTORS. 5 6 Additional SMALL-BORE CONNECTOR APPLICATIONS . 6 7 PROCEDURE to assess a proposed new design of SMALL-BORE CONNECTOR for inclusion in this series of sta

48、ndards 6 7.1 General 6 7.2 Proposal initiation 6 7.3 PROCEDURE to assess acceptability and NON-INTERCONNECTABLE characteristics 7 7.3.1 Design . 7 7.3.2 Design realization 7 7.3.3 Design VERIFICATION 7 7.3.4 Design validation . 8 7.4 Design review . 8 7.5 Subsequent parts of this series of standards

49、. 8 Annex A (informative) Rationale 9 Annex B (normative) Mechanical tests for verifying NON-INTERCONNECTABLE characteristics . 12 Annex C (informative) APPLICATIONS of SMALL-BORE CONNECTORS 13 Annex D (informative) Reference to the Essential Principles. 15 Bibliography 17 Terminology Alphabetized index of defined terms 18 Glossary of equivalent standards vi Committee representation. viii Background of AAMI adoption of ISO 80369-1:2010 . x Foreword . xiIntroduction . xiivi 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 80369-1:2010 Glossary o